Import Alert 25-19

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 25-19

Published Date: 09/15/2015

Type: DWPE with Surveillance

Import Alert Name:

"Detention Without Physical Examination of Fresh Garlic and Garlic Products Due to Mold"

Reason for Alert:

In the last six months, LOS-DO has reported an increase in the number of detentions and refusals of fresh garlic from the Peoples Republic of China (PRC) due to mold/decomposition and/or insect filth/damage. Of 13 shipments of fresh garlic entered from 09/01/93 to 03/07/94 that have been sampled and analyzed, 10 shipments (77% detention rate) have been detained with the percentage of rejects due to old/decomposition/insect filth ranging from 24% to 61.1%. This detention rate represented 10 different PRC manufacturers/shippers.

During this same time period, New York district had detained 8 of 11 shipments (73% detention rate) of fresh garlic from 3 different PRC manufacturers/shippers. Percentages of rejects for old/ decomposition/insect damage ranged from 12% to 48%.

Seattle district reported detaining and refusing garlic products due to decomposition. These had been repacked and processed by Canadian firms using garlic products from PRC.

Orlando district (HFR-SE240) reported that shipments of fresh garlic from Argentina, represented by sample numbers 1898962 and 1898975, were found to contain decomposition, mold and insect filth and sample number 1898987, was found to contain mold and insect filth, which may have adverse consequences if consumed.

Guidance:

Districts may detain, without physical examination, fresh garlic and garlic products from manufacturers/shippers listed in the attachment for this alert.

Continued surveillance of other firms shipping or processing garlic and garlic products is also warranted.

When districts encounter multiple violative shipments of fresh garlic from the same manufacturers/shippers, recommendation for detention without physical examination of Fresh Garlic and Garlic Products Due to Moldand accompanying information, including laboratory worksheets, should be forwarded to Division of Import Operations and Policy, HFC-170.

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance or to be otherwise unfit for food as it appears to contain mold, and/or insect filth, and/or appears to be decomposed [Adulteration, Section 402(a)(3)]."